Indications and uses
■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ backache ■ minor pain of arthritis ■ toothache ■ the common cold ■ premenstrual and menstrual cramps ■ temporarily reduces fever
■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ backache ■ minor pain of arthritis ■ toothache ■ the common cold ■ premenstrual and menstrual cramps ■ temporarily reduces fever
■ do not take more than directed adults and children 12 years and over ■ take 2 gelcaps every 6 hours while symptoms last ■ do not take more than 6 gelcaps in 24 hours, unless directed by a doctor ■ do not take more than 10 days unless directed by a doctor children under 12 years ■ ask a doctor
■ store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature ■ avoid high humidity ■ see end panel for lot number and expiration date
(in each Gelcap)
Acetaminophen, USP 500 mg
Pain reliever/fever reducer
■ temporarily relieves minor aches and pains due to:
■ headache
■ muscular aches
■ backache
■ minor pain of arthritis
■ toothache
■ the common cold
■ premenstrual and menstrual cramps
■ temporarily reduces fever
This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 4,000 mg of acetaminophen in 24 hours
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product
acetaminophen may cause severe skin reactions. Symptoms may include:
■ skin reddening
■ blisters
■ rash
If a skin reaction occurs, stop use and seek medical help right away.
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
■ if you have ever had an allergic reaction to this product or any of its ingredients
liver disease.
taking the blood thinning drug warfarin.
■ pain gets worse or lasts more than 10 days
■ fever gets worse or lasts more than 3 days
■ new symptoms occur
■ redness or swelling is present
These could be signs of a serious condition.
ask a health professional before use.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
■ do not take more than directed
adults and children 12 years and over
■ take 2 gelcaps every 6 hours while symptoms last
■ do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
■ do not take more than 10 days unless directed by a doctor
children under 12 years
■ ask a doctor
■ store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature
■ avoid high humidity
■ see end panel for lot number and expiration date
ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red#33, FD&C blue#1, FD&C red#40, FD&C yellow#6, gelatin, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hypromellose, iron oxide red, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, yellow iron oxide.
call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69842-491-40 | 2023-03-02 | C162847 | 48780-1 | f386c64a-27c7-0266-e053-dadaa90a7c1a | Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free |
| 69842-491-40 | 2023-03-02 | C162847 | 48780-1 | f386c64a-27c7-0266-e053-dadaa90a7c1a | Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free |
| 69842-491-40 | 2023-01-30 | C162847 | 48780-1 | f386c64a-27c7-0266-e053-dadaa90a7c1a | Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free |
| 69842-491-40 | 2023-01-30 | C162847 | 48780-1 | f386c64a-27c7-0266-e053-dadaa90a7c1a | Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69842-491-40 | Acetaminophen | 400 in 1 BOTTLE | TABLET | 400 | 8 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69842-491 | 69842-491-40 |
Every source-derived ingredient row is available through these pages.
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 7 | 2025-12-11 | legacy-cache | 2026-10-21 17:51:34 |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN | CVS PHARMACY, INC | c2c6d6a1-b492-506d-e053-2995a90aac23 | 2025-12-19 | Warnings | 69842-491-40 69842-491 69842049140 46547277-f128-b9e7-e063-6294a90a2ccd c2c6d6a1-b492-506d-e053-2995a90aac23 |
Adverse event summaries are temporarily unavailable. Other product information remains available.